510(k) Clearances in 2018 — Page 55

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 55 of 62)
510(k) clearancesDetails
K173636 — VelocityVarian Medical Systems, Inc. Feb 15, 2018
K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc. Feb 15, 2018
K173750 — Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. Feb 15, 2018
K173565 — Sunrise 6200, Sunrise 7200Jk-Holding GmbH Feb 14, 2018
K173185 — SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation Feb 14, 2018
K172439 — Siberian FitVydence Feb 14, 2018
K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC Feb 14, 2018
K180158 — Surgical Laser fibersQuanta System Spa Feb 14, 2018
DEN170045 — Banyan BTIBanyan Biomarkers, Inc. Feb 14, 2018
K173567 — SeraInteracoustics A/S Feb 14, 2018
K173545 — TEMED Gas DiffuserTemed Feb 14, 2018
K173315 — SupaChair Powered WheelchairEurogreen International, Inc. Feb 13, 2018
K172870 — Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JHangzhou Hua'An Medical&Health Instruments Co.,Ltd Feb 13, 2018
K173535 — Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion DeviceTitan Spine, LLC Feb 13, 2018
K173195 — DRI Hydrocodone AssayMicrogenics Corporation Feb 13, 2018
K173592 — MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. Feb 13, 2018
K173313 — SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SPEurogreen International, Inc. Feb 13, 2018
DEN170073 — ContaCTViz.Al, Inc. Feb 13, 2018
K172839 — ENDOSOLVSeptodont Feb 13, 2018
K172058 — CT6485, CT12885Analogic Corporation Feb 13, 2018
K171825 — Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. Feb 13, 2018
K180288 — QuickVue Influenza A+BQuidel Corporation Feb 13, 2018
K172624 — Voyant 5mm Fusion DeviceApplied Medical Resources Corporation Feb 13, 2018
K172941 — CASCADIA Interbody SystemK2M Feb 12, 2018
K170793 — SuRgical Planner (SRP)Surgical Theater, LLC Feb 12, 2018
K173561 — Vinyl Patient Examination Glove (Yellow)Yurun Glove Co., Ltd. Feb 12, 2018
K173579 — Thorecon™ Fixation SystemA & E Medical Corporation Feb 12, 2018
K171495 — Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. Feb 12, 2018
K172775 — MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. Feb 12, 2018
K173670 — CELERITY 20 Steam IncubatorSTERIS Corporation Feb 12, 2018
K180118 — Arthrex NanoSuture AnchorArthrex, Inc. Feb 12, 2018
K173634 — CELERITY 20 Steam Biological IndicatorSTERIS Corporation Feb 12, 2018
K173710 — MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC Feb 12, 2018
K173527 — Digitex Delivery DeviceColoplast A/S Feb 12, 2018
K172883 — Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd. Feb 12, 2018
K171933 — ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd. Feb 12, 2018
K180082 — geko T-2 and geko Plus R-2Firstkind, Ltd. Feb 11, 2018
K170131 — TAV Medical Dental Implants SystemTav Medical , Ltd. Feb 10, 2018
K172160 — Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd. Feb 9, 2018
K173823 — Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography SystemSummit Industries, LLC Feb 9, 2018
K173163 — ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. Feb 9, 2018
K172180 — OSCAR 15Genoray Co., Ltd. Feb 9, 2018
K172748 — VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations Feb 9, 2018
K172751 — iVitri StrawReprobitech Corp. Feb 9, 2018
K180107 — Blue Sky Bio AlignerBlue Sky Bio, LLC Feb 9, 2018
K172752 — CELERITY 20 HP Biological IndicatorSTERIS Corporation Feb 9, 2018
K171179 — BR Type Implant SystemBiotem Co., Ltd. Feb 9, 2018
K172755 — PRO-LITE Sterilization TraysSTERIS Corporation Feb 9, 2018
K173894 — Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc. Feb 9, 2018
K172749 — Vis-U-All Low Temperature Sterilization Pouch/TubingSTERIS Corporation Feb 9, 2018
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